Pegfilgrastim is indicated to decrease the incidence of
infection, as manifested by febrile neutropenia, in patients with non-myeloid
malignancies receiving myelosuppressive anti-cancer drugs associated with a
clinically significant incidence of febrile neutropenia.
No formal drug interaction studies between Pegfilgrastim and
other drugs have been performed. Increased hematopoietic activity may result in
transiently positive bone-imaging changes—this should be considered when
interpreting diagnostic results. Pegfilgrastim must not be mixed with other
medicinal products, particularly sodium chloride solutions.
The recommended dosage in adults is a single subcutaneous
injection of 6 mg administered once per chemotherapy cycle. Do not administer
Pegfilgrastim between 14 days before and 24 hours after administration of
cytotoxic chemotherapy.
Do not administer Pegfilgrastim to patients with a history
of serious allergic reactions to pegfilgrastim or filgrastim.
Serious adverse reactions include splenic rupture (including
fatal cases), acute respiratory distress syndrome (ARDS), serious allergic
reactions (including anaphylaxis), and sickle cell crises in patients with
underlying sickle cell disorders.
Other reported side effects include peripheral edema,
asthenia, headache, vomiting, bone pain, myalgia, weakness, alopecia, pyrexia,
hyperuricemia, elevated LDH or alkaline phosphatase levels, and allergic
reactions.
Pegfilgrastim is classified as Pregnancy Category C. Animal
studies suggest embryotoxicity and increased pregnancy loss at high doses, and
it should be used only if the potential benefit justifies the risk to the
fetus. It is unknown whether Pegfilgrastim is secreted in human milk;
recombinant G-CSF products are poorly secreted, and G-CSF is not orally
absorbed in neonates, but caution is advised.
Fatal splenic rupture has been reported. Evaluate for
splenomegaly or splenic rupture in patients reporting left upper abdominal or
shoulder pain. ARDS may occur—discontinue Pegfilgrastim if suspected. Serious
allergic reactions should lead to permanent discontinuation. Use caution in
patients with sickle cell disorders due to the risk of severe sickle cell
crises.
The maximum safe dose of Pegfilgrastim has not been
established. Single subcutaneous doses up to 300 µg/kg have been administered
without serious adverse events, resulting in elevated absolute neutrophil and
white cell counts.
Pegfilgrastim should be stored refrigerated at 2–8 °C. Do
not freeze, shake, or expose to light.
